Itchins M, Arena J, Nahm C B, Rabindran J, Kim S, Gibbs E, Bergamin S, Chua T C, Gill A J, Maher R, Diakos C, Wong M, Mittal A, Hruby G, Kneebone A, Pavlakis N, Samra J, Clarke S
Department of Oncology, Royal North Shore Hospital, Sydney, NSW, Australia; Sydney Medical School (Northern), The University of Sydney, Australia.
Department of Oncology, Royal North Shore Hospital, Sydney, NSW, Australia.
Eur J Surg Oncol. 2017 Sep;43(9):1711-1717. doi: 10.1016/j.ejso.2017.06.012. Epub 2017 Jun 28.
Pancreatic ductal adenocarcinoma (PDAC) is a deadly disease. Neoadjuvant therapy (NA) with chemotherapy (NAC) and radiotherapy (RT) prior to surgery provides promise. In the absence of prospective data, well annotated clinical data from high-volume units may provide pilot data for randomised trials.
Medical records from a tertiary hospital in Sydney, Australia, were analysed to identify all patients with resectable or borderline resectable PDAC. Data regarding treatment, toxicity and survival were collected.
Between January 1 2010 and April 1 2016, 220 sequential patients were treated: 87 with NA and 133 with upfront operation (UO). Forty-three NA patients (52%) and 5 UO patients (4%) were borderline resectable at diagnosis. Twenty-four borderline patients received NA RT, 22 sequential to NAC. The median overall survival (OS) in the NA group was 25.9 months (mo); 95% CI (21.1-43.0 mo) compared to 26.9 mo (19.7, 32.7) in the UO; HR 0.89; log-ranked p-value = 0.58. Sixty-nine NA patients (79%) were resected, mOS was 29.2 mo (22.27, not reached (NR)). Twenty-two NA (31%) versus 22 UO (17%) were node negative at operation (N0). In those managed with NAC/RT the mOS was 29.0 mo (17.3, NR). There were no post-operative deaths with NA within 90-days and three in the UO arm.
This is a hypothesis generating retrospective review of a selected real-world population in a high-throughput unit. Treatment with NA was well tolerated. The long observed survival in this group may be explained by lymph node sterilisation by NA, and the achievement of R0 resection in a greater proportion of patients.
胰腺导管腺癌(PDAC)是一种致命疾病。术前采用化疗(NAC)和放疗(RT)的新辅助治疗(NA)带来了希望。在缺乏前瞻性数据的情况下,来自大型医疗单位的详细注释临床数据可为随机试验提供初步数据。
分析了澳大利亚悉尼一家三级医院的病历,以确定所有可切除或边界可切除的PDAC患者。收集了有关治疗、毒性和生存的数据。
在2010年1月1日至2016年4月1日期间,连续治疗了220例患者:87例接受新辅助治疗,133例接受 upfront 手术(UO)。43例新辅助治疗患者(52%)和5例 upfront 手术患者(4%)在诊断时为边界可切除。24例边界可切除患者接受了新辅助放疗,22例在化疗后进行。新辅助治疗组的中位总生存期(OS)为25.9个月(mo);95%置信区间(21.1 - 43.0 mo),而 upfront 手术组为26.9 mo(19.7,32.7);风险比0.89;对数秩检验p值 = 0.58。69例新辅助治疗患者(79%)接受了手术,中位总生存期为29.2 mo(22.27,未达到(NR))。22例新辅助治疗患者(31%)与22例 upfront 手术患者(17%)在手术时淋巴结阴性(N0)。在接受化疗/放疗的患者中,中位总生存期为29.0 mo(17.3,NR)。新辅助治疗组90天内无术后死亡,upfront 手术组有3例。
这是对高通量医疗单位中选定的真实世界人群进行的一项产生假设的回顾性研究。新辅助治疗耐受性良好。该组长期观察到的生存期可能是由于新辅助治疗使淋巴结清除,以及更大比例的患者实现了R0切除。